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Gene patent decision A US court's decision that naturally occurring genes cannot be patented could have an impact on a similar case in Australia.

Overnight, the US Supreme Court unanimously ruled that genes extracted from the human body were not eligible to be patented.

But the court said legal protections could be retained on synthetically produced genetic material, when these molecules are "not naturally occurring."

The ruling by the nine justices, the first of its kind for the top US court, also allows the possibility of patents for applications of genetic knowledge such as treatments and tests.

The court's ruling came in a challenge launched by medical researchers and others to seven patents owned by or licensed to biotechnology company Myriad Genetics on two genes linked to breast and ovarian cancer, called BRCA1 and BRCA2.

The decision comes five weeks before Australian Federal Court judges are due to consider an appeal against a ruling that upheld the ability to patent human genes, handed down in February.

Bill Madden, an adjunct fellow at the University of Western Sydney, and a lawyer with Slater & Gordon Limited, says the Australian court would study the US decision carefully.

"When you get to these fairly esoteric legal issues, there's no doubt that the superior courts in different countries look at each other to see how they've grappled with things," says Madden.

"That doesn't mean that they always come to the same conclusion but it would be pretty surprising if the full Federal Court wasn't given a copy of the Supreme Court decision and asked to read it."

Australian opponents of gene patenting hope the Federal Court will echo the findings of its US counterpart.

"The Australian appeal is about whether an isolated gene is patentable. The Americans have made it very clear that it isn't," says Olver.

"We'd like to see a decision in line with that and legislation to change the patent act so that genes, whether in the body or isolated, aren't patentable here."

Natural v synthetic

Dr Luigi Palombi, an expert on biotechnology patents from the Australian National University, says the US ruling hinges on a decision that isolating a human gene or part of a human gene is not an act of invention.

On the other hand, DNA sequences produced in laboratories could be patentable, "provided that the information contained in it is not identical to what exists in nature," he says.

These synthetic DNA sequences include so-called cDNA -- the "c" stands for "complementary" -- which are edited forms of a gene, with extraneous stretches excised.

Retaining the possibility of patenting synthetic DNA means the Supreme Court decision is not a setback for the biotech industry, say US experts.

"There are literally tens of thousands of patents claiming DNA that we would not consider to be a product of nature," and which therefore are fine according to the US Supreme Court's decision, says Gregory Graff, a professor at Colorado State University, who led an analysis of gene patents published last month in Nature Biotechnology.

Impact on women

The ruling also makes it clear that US scientists working with genetic material are not at risk of being sued for patent infringement, says Palombi.

"American companies and universities are [now] free to use the genetic material to come up with new inventions. That might be a new diagnostic test, or a medicine of some kind."

Palombi says the test would also improve BRCA testing for American women as more labs would be able to test for mutations in the gene, and the price of testing was likely to drop significantly.

"A number of companies have already announced that they are going to be bringing out their own version of the test in the United States," he says.

In Australia, BRCA testing is already provided by a number of laboratories. After a public pressure, the company that has an exclusive licence from Myriad Genetics, Genetic Technologies, decided not to enforce its patent rights over the genes.

He argues patent protection is vital to ensure private companies help commercialise scientific work and bring it to the public. Tampering with patent law is not needed to ensure equity of access or pricing of tests, he says.

"I do not for one minute think that this will improve equity of access for the test in the US or anywhere else. I fundamentally disagree that changing the patent system is the solution."

Nor would removing patent protection on genes hamper medical research, he said. "It's absolute nonsense that patents hinder research. I've been in this game for decades and I've never, ever seen that happen."